Endodontic Microsurgery With the Use of L-PRF Block

Universitaire Ziekenhuizen KU Leuven20 enrolled

Overview

This study evaluates the effect of leucocyte and platelet rich fibrin Block (L-PRF Block) during endodontic microsurgery (EMS) on patient's post-operative comfort and periapical bone healing in large peri-apical lesions. The trial design is an open randomized controlled clinical trial with two groups. Half of the participants will receive EMS with L-PRF Block (experimental group), the other half without (control group).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Apical Periodontitis Apical Periodontal Cyst

Interventions

Endodontic MicrosurgeryPROCEDURE

Surgical removal of 3 millimeters of the root-end, removal of the apical pathology, Root-end preparation and retrograde filling. The entire procedure is done under magnification.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria * Provision of Informed Consent * Patients from 18 years old * Patients in need of an EMS * EMS is the only option to cure the periapical lesion * A periapical lesion that has a diameter of 10mm or more in sagittal plane, frontal plane or axial plane when measured on CBCT Exclusion Criteria * Unlikely to be able to comply with the study procedures, as judged by the investigator * Orthograde endodontic (re)treatment is indicated * Known or suspected current malignancy * History of chemotherapy within 5 years prior to study * History of radiation in the head and neck region * History of other metabolic bone diseases * History of bleeding disorders * HIV disease * Hepatitis B or C * Systemic disease (osteoporosis, diabetes…)

Locations (1)

UZ Leuven

Leuven, Vlaams-Brabant, Belgium

RECRUITING

Outcomes

Primary Outcomes

Amount of peri-apical bone healing

Amount of periapical bone healing in time: measured with Cone Beam Computed Tomography (CBCT).

Time frame: 1 year

Secondary Outcomes

Patient related outcomes

Pain assessed with a Visual Analogue Scale ranging from 0 to 10 each day during the first 7 days post-op.

Time frame: 7 days

Patient related outcomes

Pain assessed with a questionnaire asking about analgesics usage each day during 7 days post-op.

Time frame: 7 days

Patient related outcomes

Discomfort assessed with a Visual Analogue Scale ranging from 1 to 5 each day during the first 7 days post-op.

Time frame: 7 days

Bone or scar tissue healing

Bone or scar tissue healing: Volumetric analysis using Cone-Beam Computed Tomography. Pre-operative CBCT data will be matched with the post-op CBCT scans in order to assess the volumetric changes during 1 year.

Time frame: 1 year

Success & survival rate

Success \& survival rate

Time frame: 1 year

Dentinal defects

Dentinal defects: in the apical root before and after resection. Potential cracks and fractures that occur during the follow-up period will be assessed on CBCT en reported.

Time frame: 1 year

Central Contacts

Nastaran Meschi, PhD

CONTACT

0032476313889 Nastaran.meschi@kuleuven.be

Joëy d'Hoop, DDS

CONTACT

0032477362532 Joey.dhoop@uzleuven.be

Data from ClinicalTrials.gov

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